NCT05702645|RecruitingDMC

A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia

Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)

Children's Oncology Group ClinicalTrials.gov

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5 other identifiers

ALTE22C1NCI-2022-09410COG-ALTE22C1R01CA263000UG1CA189955

Study Type

observational

Target

330

Locations

2 countries

Sites

Timeline

RegisteredJan 2023

StartedNov 2023

CompletionJun 2029

Brief Summary

This study attempts to learn more about the health of persons with Down syndrome after treatment for acute leukemia. Children with Down syndrome are at increased risk for side effects during treatment for acute leukemia, but it is unclear of their risk for long-term effects of cancer treatment. By learning more about the factors that may contribute to chronic health conditions and long-term effects after treatment for leukemia in persons with Down syndrome, clinical practice guidelines for survivorship care can be developed to help improve their quality-of-life.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

330

participants targeted

Target at P75+ for all trials

Timeline

38mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach

2 countries

70 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.6 years study duration

Study Progress44%

Nov 2023Jun 2029

First Submitted

Initial submission to the registry

January 9, 2023

Completed

18 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed

10 months until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

5.6 years

First QC Date

January 9, 2023

Last Update Submit

May 1, 2026

Conditions

B Acute Lymphoblastic Leukemia Associated With Down Syndrome Down Syndrome Myeloid Leukemia Associated With Down Syndrome

Outcome Measures

Primary Outcomes (1)

Prevalence, type, and severity of chronic health conditions (CHC)
Summary statistics will be used to characterize the study populations on CHC outcomes. Quantitative data (number of comorbidities) will be summarized using descriptive statistics and correlational techniques. Will use pooled logistic regression to estimate overall response, 95% confidence interval (CI), and p-values for association of acute leukemia (AL) diagnosis with medical record-verified CHC, agnostic of time to CHC. Will use stratified Cox models to refine associations of AL diagnosis with CHC based on time to CHC incidence. Within each age interval, will estimate the hazard ratio, 95% CI, and p-values to report time-dependent effects of AL diagnosis on CHC.
Up to study completion

Secondary Outcomes (5)

Post-treatment clinical outcomes
Up to study completion
Prevalence and severity of parent-proxy neuropsychological (NP) outcomes
Up to study completion
Health-related quality of life (HRQOL)
Up to study completion
Clinical risk determinants of CHC, NP, and clinical outcomes
Up to study completion
Well-annotated cohort of Down syndrome phenotyping acute leukemia study (DS-PALS) survivors and associated biobank
Up to study completion

Other Outcomes (2)

Structural birth defects and genetic associations with etiology extending to CHC for Down syndrome acute lymphoblastic leukemia (DS-ALL)
Up to study completion
Telomere length (TL) determined by polygenic risk score and telomere flow-fluorescence in situ hybridization (FISH) in association with outcomes from in-person NP assessment for DS-ALL
Up to study completion

Study Arms (1)

Observational (biospecimen collection, clinical evaluation)

Patients undergo an optional saliva/buccal swab in part 1 and clinical assessment in part 2 of the study. Patients with DS-ALL may then undergo blood sample collection and neurocognitive assessment in part 3 of the study.

Procedure: Biospecimen CollectionOther: Clinical EvaluationOther: Neurocognitive AssessmentOther: Questionnaire AdministrationOther: Survey Administration